Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Hematology ×
3,297 results
1633–1656 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Jan 31, 1992
HEMOPLUS
K913622 · KHE
Sarstedt, Inc.
Hematology · 170d
Cleared Jan 31, 1992
D-DIMER WELLCOTEST (HA10)
K915203 · DAP
Wellcome Diagnostics
Hematology · 74d
Cleared Jan 30, 1992
FIBRINOGEN FDP CONTROL
K915503 · DAP
Cala Diagnostics
Hematology · 52d
Cleared Jan 23, 1992
ACTIVATED PARTIAL THROMBOPLASTIN TIME
K915463 · GGW
Sigma Diagnostics, Inc.
Hematology · 50d
Cleared Jan 17, 1992
DIFFERENTIAL COUNTING BOARD
K915071 · GKZ
Biovation, Inc.
Hematology · 70d
Cleared Jan 15, 1992
DADE(R) ALPHA 2 ANTIPLASMIN(2 2-AP) CHROMO ASSAY
K914818 · GGP
Baxter Diagnostics, Inc.
Hematology · 82d
Cleared Jan 13, 1992
CASCADE 480(TM) AUTO COAG ANALYZER, MODIFICATION
K914946 · GKP
Helena Laboratories
Hematology · 76d
Cleared Jan 08, 1992
MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGE
K915441 · GKF
Fisher Scientific Co., LLC
Hematology · 35d
Cleared Jan 06, 1992
PROTEIN S EID KIT AND PROTEIN S EID BULK PLATES
K915163 · GGP
Biopool AB
Hematology · 53d
Cleared Jan 03, 1992
ANTITHROMBIN III IMMUNOLOGICAL NL TEST KIT
K913667 · JBQ
The Binding Site, Ltd.
Hematology · 137d
Cleared Jan 03, 1992
COAMATE(R) ANTITHROMBIN CHROMOGENIC ASSAY
K915083 · JBQ
Kabi Pharmacia, Inc.
Hematology · 52d
Cleared Dec 30, 1991
SYSMEX NE-1500, MODIFICATION
K914744 · GKZ
Toa Medical Electronics USA, Inc.
Hematology · 69d
Cleared Dec 17, 1991
COLUMNMATE(TM) BETA-THAL CAT. NO. 4515
K913384 · JPD
Helena Laboratories
Hematology · 141d
Cleared Dec 09, 1991
SPECTROLYSE PROTEIN C KIT
K914307 · GGP
Biopool AB
Hematology · 75d
Cleared Dec 04, 1991
ACS ULTRA-1 THROMBOPLASTIN
K913249 · GJS
Analytical Control Systems, Inc.
Hematology · 135d
Cleared Dec 04, 1991
FACSTRAK FLOW CYTOMETER
K914014 · GKZ
Bd Becton Dickinson Vacutainer...
Hematology · 86d
Cleared Dec 02, 1991
FRUCTOSAMINE ABG21 TEST SYSTEM
K913614 · LCP
Boehringer Mannheim Corp.
Hematology · 111d
Cleared Nov 29, 1991
EPO-RIA
K910481 · GGT
Ramco Laboratories, Inc.
Hematology · 296d
Cleared Nov 27, 1991
ACS ULTRA-2 THROMBOPLASTIN
K913250 · GJS
Analytical Control Systems, Inc.
Hematology · 128d
Cleared Nov 27, 1991
CBC-8K(TM) HEMATOLOGY CONTROL/MULTIPLE
K913879 · JPK
R&D Systems, Inc.
Hematology · 90d
Cleared Nov 22, 1991
CELL-DYN 3000A MULTI-PARAMETER AUTO HEMA ANALZYER
K913305 · GKZ
Unipath , Ltd.
Hematology · 120d
Cleared Nov 19, 1991
SICKLE HEMOGLOBIN (HBA/S) CONTROL SET
K913427 · JCM
Creative Laboratory Products, Inc.
Hematology · 110d
Cleared Oct 31, 1991
MONOCLONAL ANTIBODY ANTI-CD19
K901186 · GKZ
Sigma Chemical Co.
Hematology · 597d
Cleared Oct 31, 1991
MONOCLONAL ANTIBODY ANTI-CD2
K901187 · GKZ
Sigma Chemical Co.
Hematology · 597d